Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Multiple center, open-label, PK study

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phillip Brian Smith
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Rifampin; Ticarcillin; Ticarcillin-clavulanic acid

Criteria

Inclusion Criteria:

• Sufficient intravascular access

• Suspected systemic infection or receiving 1 of the study drugs per standard of care

• informed consent from legal guardian

Exclusion Criteria:

• history of allergic reaction to study drugs

• urine output <0.5 mL/hr/kg over the prior 24 hours

• serum creatinine >1.7 mg/dl

• Any condition in investigator judgment precludes participation because it could affect participant safety